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HEP. A VACC. PURIFIED INACTIVATED FOR ADOLESCENTS AND PAEDIACTRICS

Active substance(s): VIRUS HEPATITIS A / VIRUS HEPATITIS A

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PACKAGE LEAFLET: INFORMATION FOR THE USER

VAQTA® Paediatric

AMS Blue Braille Grid Version: 29.1 - 05-04-16

Suspension for injection
Hepatitis A vaccine, inactivated, adsorbed
For children and adolescents
Read all of this leaflet carefully before you or your child is vaccinated
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
• If you or your child gets any side effects talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Vaqta Paediatric is and what it is used for
2. What you need to know before Vaqta Paediatric is given
3. How Vaqta Paediatric is given
4. Possible side effects
5. How to store Vaqta Paediatric
6. Contents of the pack and other information
1. What VAQTA Paediatric is and what it is used for
Vaqta Paediatric is one of a general group of medicines called vaccines.
Vaccines are used to protect against infectious diseases. They work by causing
the body to produce its own protection against the targeted disease.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A is a virus that attacks the liver, which can be caught from food or
drink that contains the virus. Symptoms of hepatitis A include a yellowing of
the skin and eyes (jaundice) and feeling generally unwell.
When an injection of this vaccine is given, the body’s natural defences will
produce protection (antibodies) against the hepatitis A infection. However,
it usually takes 2 to 4 weeks after receiving the injection before you or your
child will be protected.
This vaccine will not protect against other viruses that infect the liver (such as
hepatitis B, hepatitis C or hepatitis E). This vaccine protects against hepatitis
A but cannot cause a hepatitis A infection.
The vaccination may not work properly if the person to be vaccinated is
already infected with the hepatitis A virus.
Vaqta Paediatric is for children from 12 months old up to 17 years old. This
vaccine is not suitable for children under 12 months of age or adults aged
18 years and over.
2. What you need to know before VAQTA Paediatric is given
Do not use Vaqta Paediatric:
• if you or your child is allergic to the active substance or any of
the other ingredients of Vaqta Paediatric (listed in section 6) or to
neomycin or formaldehyde (see section ‘Warnings and precautions’).
• if you or your child is ill with a high temperature. The vaccination
should be delayed until you or your child has recovered.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Vaqta Paediatric is given:
• if you or your child has ever had an allergic reaction to a previous dose
of Vaqta Paediatric. This vaccine may contain traces of an antibiotic
called neomycin and a substance called formaldehyde, both of which
are used during vaccine production and may be present in the vaccine
in trace amounts.
• if you or your child has a poor or reduced immune system, due to:
– corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or
nurse may wait until the treatment has finished.
– HIV (human immunodeficiency virus infection) or any disease that
affects the immune system. The vaccine may not protect as well as
it protects people whose immune system is healthy.
• if you or your child has any problems with the blood that causes easy
bruising or bleeding for a long time after minor cuts. Your doctor
or nurse may still advise that you or your child should have Vaqta
Paediatric but extra care is needed because of the risk of bleeding at
the injection site. Your doctor or nurse may give Vaqta Paediatric as an
injection under the skin instead of into muscle (see section 3) to try to
reduce the risk of deep bleeding.
The container of this medicinal product contains latex rubber. May cause
severe allergic reactions.

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As with other vaccines, Vaqta Paediatric may not completely protect all
persons who are vaccinated.
Please tell your doctor if you or your child have had a history of jaundice
or have lived in an area where hepatitis A is common. Your doctor will
determine whether you or your child should be tested for hepatitis A
antibodies prior to vaccination.
Other medicines and VAQTA Paediatric
Tell your doctor or pharmacist if you or your child is taking, has recently taken
or might take any other medicines (or other vaccines).
This vaccine can be given at the same time as any of the following provided
that they are given in different parts of the body (for example another arm or
leg) and are not mixed in the same syringe.
• Measles, mumps, rubella and varicella (chickenpox) virus vaccines,
• Pneumococcal 7-valent conjugate vaccine,
• Polio vaccine (Inactivated),
• Diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus
influenzae b vaccines,
• Immunoglobulins (antibodies obtained from blood donors)
In adults, Vaqta may be given at the same time as yellow fever and
polysaccharide typhoid vaccines.
Pregnancy, breast-feeding and fertility
If you or your child is pregnant or breast-feeding, think you or your child may
be pregnant or is planning to have a baby, ask your doctor or pharmacist for
advice whether you or your child should receive the vaccine.
Driving and using machines
There are no data to suggest that Vaqta Paediatric affects the ability to drive
or operate machinery.
Vaqta Paediatric contains less than 1 mmol sodium (1.78 mg) per dose,
i.e. essentially ‘sodium-free’.
3. How VAQTA Paediatric is given
The vaccine will be injected by a doctor or nurse who has been trained in
the use of vaccines and who is equipped to deal with any rare severe allergic
reaction to the injection.
Short term protection against hepatitis A is achieved within 2 to 4 weeks after
receiving this vaccination.
Long term protection against hepatitis A requires a second dose (booster)
injection of an inactivated hepatitis A vaccine. This is usually given between 6
and 18 months after the first dose. Healthy children who have had two doses
have been found to have antibody levels for at least 10 years. It is predicted
that hepatitis A antibodies will remain at least 25 years after vaccination.
Safety and effectiveness in infants < 12 months of age have not been
established.
Method of administration
The doctor or nurse will shake the syringe immediately before use and check
that the liquid is white and cloudy and that there are no large particles.
The vaccine is given as an injection into a muscle in the upper outer part of
the arm (deltoid muscle). The muscle in the outer thigh region may be used
in children if the deltoid muscle is not sufficiently developed. Your doctor or
nurse will avoid giving you or your child the injection either into the skin or
into a blood vessel. Children who are at risk of bleeding a lot after an injection
(see section 2) may sometimes be given Vaqta Paediatric as an injection under
the skin but not into muscle to try to reduce the risk of bleeding.
4. Possible side effects
Like all medicines and vaccines, this vaccine can cause side effects, although
not everybody gets them.
As with all vaccines, allergic reactions, in rare cases leading to shock, may
occur. These reactions may include:
- hives
- difficulty in breathing
- swelling of the face, tongue and throat
- dizziness
- collapse
When these signs or symptoms occur they usually develop very quickly after
the injection is given and while you or your child is still in the clinic or doctor’s
surgery. If any of these symptoms occur after leaving the place where you
or your child’s injection was given, contact a doctor IMMEDIATELY.

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Side effects reported in children aged 12 months to 23 months
Frequency of side
effects
Very common: may
affect more than 1 in 10
children
Common: may affect up
to 1 in 10 children

AMS Blue Braille Grid Version: 29.1 - 05-04-16

Uncommon: may affect
up to 1 in 100 children

Rare: may affect up to 1
in 1,000 children

Not known: frequency
cannot be estimated
from the available data

Side effects
injection-site pain/tenderness and injection-site
redness
- injection-site swelling, injection-site warmth,
injection-site bruising
- f ever
- irritability
-d
 iarrhoea
-d
 ecreased or loss of appetite
- t rouble sleeping, sleepiness, feeling of tirednessdrowsiness, or lack of energy, restlessness
- c rying
- r unny nose, cough, nasal congestion
- v omiting
- r ash, diaper rash
- f eeling unwell
- injection-site lump, injection-site rash
-m
 ultiple allergies
-d
 ehydration
- a gitation, nervousness, fear, screaming
-d
 izziness, headache, loss of balance
- e yelid margin crusting
- a sthma, blocked airways, sneezing, runny or itchy
nose, mouth and throat pain
- n ausea, stomach pain/discomfort, excessive gas in
the stomach or bowel, frequent bowel movements,
belching, infantile spitting up, constipation,
discoloured faeces
- r ash, itching and redness of the skin, blisters,
clammy or warm skin, sweating
- inflamed joints
- a t injection-site: bleeding, itching, discoloration,
lump formation or an itchy rash; pain, discomfort
- f atigue, abnormality with manner of walking,
feeling hot
-G
 uillain-Barré syndrome (muscle weakness,
abnormal sensations, tingling in the arms, legs and
upper body)
- t hrombocytopenia (reduction in blood platelets
which increases risks of bleeding and bruising)

Side effects reported in children aged 2 years to 17 years
Frequency of side
effects
Very common: may
affect more than 1 in
10 children
Common: may affect up
to 1 in 10 children
Uncommon: may affect
up to 1 in 100 children

Rare: may affect up to 1
in 1,000 children

Not known: frequency
cannot be estimated
from the available data

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Side effects
- injection-site pain and tenderness
- h eadache
- injection-site warmth, redness and swelling,
fever, bleeding under the skin at the injection site
(ecchymosis)
- irritability
-d
 izziness
- s tomach ache, vomiting, diarrhoea, nausea
- r ash, itching
- a rm pain (in the injected limb), joint pain, muscle
pain
-w
 eakness/tiredness, injection-site itching and pain/
soreness
- loss of appetite
- n ervousness
- sleepiness, abnormal skin sensations such as tingling
- e ar ache
- f lushing
- r unny or blocked nose, cough
- h ives, sweating
- s tiffness
- h ardness (induration) at the injection-site, flu-like
illness, chest pain, pain, warmth, injection-site scab,
stiffness/tightness and stinging
-G
 uillain-Barré syndrome (muscle weakness, abnormal
sensations, tingling in the arms, legs and upper body)
- t hrombocytopenia (reduction in blood platelets
which increases risks of bleeding and bruising)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store VAQTA Paediatric
Keep this vaccine out of the sight and reach of children.
The vaccine should not be used after the expiry date (Exp) which is stated on
the carton and syringe or vial label.
The vaccine must be stored in a refrigerator between 2°C and 8°C (making
sure that it does not freeze) so that the vaccine keeps its effectiveness.
Do not use this vaccine if you notice that it has an unusual appearance (see
section 6) or contains particulate matter.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Vaqta Paediatric contains
The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5
human diploid cells, adsorbed on aluminium hydroxyphosphate sulphate).
One dose (0.5 mL) contains 25U hepatitis A virus (inactivated) adsorbed on
aluminium hydroxyphosphate sulphate (0.225 milligram as aluminium).
The other ingredients are:
• sodium borate
• sodium chloride
• water for injections
What Vaqta Paediatric looks like and contents of the pack
A pre-filled syringe or vial containing 0.5 millilitre (one dose) of the vaccine.
The vaccine is available in single packs of the vial or pre-filled syringe with or
without a needle.
Not all presentations may be marketed.
After thorough agitation, Vaqta Paediatric is an opaque white suspension.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom
Manufacturer
The manufacturer responsible for batch release at the following
manufacturing sites is:
Merck Sharp and Dohme B.V.,
Waarderweg 39,
PO Box 581,
2003 PC Haarlem,
Netherlands
This leaflet was last revised in January 2017.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.VAQ-P.16.UK.4935-COO
--------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be
mixed with other medicinal products.
Instructions for use and handling
The vaccine should be used as supplied.
The vaccine should be inspected visually prior to administration for any
foreign particulate matter and/or abnormal physical appearance. Discard the
product if particulates are present or if it appears discoloured. The syringe
should be well shaken until a slightly opaque white suspension is obtained.
Thorough agitation is necessary to maintain suspension of the vaccine. For
syringe without attached needle, hold the syringe barrel and attach the
needle by twisting in clockwise direction until the needle fits securely on the
syringe and give the vaccine immediately.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.VAQ-P.16.UK.4935-COO

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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